RE: CE Marking Passive devices
The wrist support is a medical device and requires a CE mark under the Medical Devices directive. Clearly there are no electrical parts in a simple wrist support, but if there were, there would still be no requirement to comply with the EMC and LV directives since these are subordinate to the requirements of the MDD. The MDD contains requirements for EMC and electrical safety performance, so there is no need to apply the broader directives. There are over 20 CE mark directives, covering a wide variety of products. At the margins, the application of a directive (or otherwise) is often as much about what the manufacturer claims for a product as the properties of the product itself. A good illustration is protective vinyl gloves. If these are sold to surgeons and medics for use in invasive medical procedures, they are medical devices and must be CE marked under the MDD. If they are used in a pathology laboratory to protect technicians when handling specimens, they are personal protective equipment and must be CE marked under the PPE Directive. If they are sold to technicians for use in the electronics industry in order to protect the components being handled, they are within the scope of none of the CE directives and therefore must not be marked. The three different requirements are mutually exclusive and while the product itself may be identical, the marking and paperwork requirements, and the approval procedures, are all different. Quite what lessons we should draw, I'm not sure, except maybe to be glad you're not a glove manufacturer! Nick. At 15:43 -0800 15/12/2000, Gary McInturff wrote: Nick, I've seen CE marks on a wrist support for sprained wrists etc. I haven't a clue what that was all about. Gary -Original Message- From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: Thursday, December 14, 2000 3:29 PM To: Courtland Thomas Cc: emcpost Subject: Re: CE Marking Passive devices Courtland, Since no one else seems to have answered your basic question, I will have a go for you. SNIP --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: CE Marking Passive devices
Nick, I've seen CE marks on a wrist support for sprained wrists etc. I haven't a clue what that was all about. Gary -Original Message- From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: Thursday, December 14, 2000 3:29 PM To: Courtland Thomas Cc: emcpost Subject: Re: CE Marking Passive devices Courtland, Since no one else seems to have answered your basic question, I will have a go for you. Passive devices and components such as cables are excluded from the EMC Directive and as such carry no CE mark under this directive. This is not to say that all components are excluded - this is a complex matter which is covered in some depth in the Commission guide to the Directive. If you don't already have a copy of this, you can download it from the Commission EUROPA server or from my company web site - mail me direct for the full URL details if you need them. However, certain passive components (e.g cable) are within the scope of the LVD and therefore require CE marking. It's unclear exactly how this works, in the sense that this seems to be one of the few areas of CE marking which is basically optional. It would be quite easy to argue that cable and wires are outside the scope of the LVD and therefore do not require a CE mark, but equally you could argue that they are within the scope and therefore should have the mark. The difference is basically made by what the manufacturer/seller claims the cable is to be used for. The advantage of carrying the mark (at least in theory) is, of course, unrestricted access to the whole EU marketplace so I guess savvy manufacturers tend to 'opt in' and mark their products. In practice, some cables, such as those which are specifically specified for use at mains voltages (e.g. house wiring, flexible cords for power connection of household appliances, etc) clearly are intended for use within the voltage limits of the LVD and must therefore be CE marked. There is an interesting (well, to CE anoraks like me, it's interesting anyway!) twist here, because fixed wiring in also within the scope of the Construction Products Directive, and CE marking is optional under this directive. However, the CPD is a whole new can of worms and it's far from clear what anyone is actually doing to comply with it, if anyone is actually seriously bothering at all. (If there's anyone else on this list with an interest in the CPD, I would be interested to hear from them, but I digress.) Again, the Commission guidance document on the LVD gives further guidance on this topic. Basically it says that if it's possible to do a safety assessment on the product, then such an assessment should take place and the CE mark should be applied, but if the component is so basic that its safety is totally reliant on how it is used then no such assessment is possible on the component itself and the CE mark should not be applied. I would tend to simplify this further and say that as a rule of thumb if there is a harmonised standard for the component under the LVD then it should be CE marked, and if there isn't it should not. To take the specific example of the surge protector, you need to be specific about that of which you speak. If you mean a component such as an MOV or a gas discharge tube, this is clearly a component and therefore outside the scope of the both LVD and the EMC Directive. If you mean an assembly in a box with connections (such as a telephone line lightning suppressor assembly) this can be assessed for safety and does require a CE mark under the LVD. An assembly such as this is not a component within the meaning of the EMC directive either, and will therefore need to comply with that directive too. Hope this sheds a little light for you. Regards Nick. At 09:36 -0800 12/12/2000, Courtland Thomas wrote: Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad
Re: CE Marking Passive devices
Courtland, Since no one else seems to have answered your basic question, I will have a go for you. Passive devices and components such as cables are excluded from the EMC Directive and as such carry no CE mark under this directive. This is not to say that all components are excluded - this is a complex matter which is covered in some depth in the Commission guide to the Directive. If you don't already have a copy of this, you can download it from the Commission EUROPA server or from my company web site - mail me direct for the full URL details if you need them. However, certain passive components (e.g cable) are within the scope of the LVD and therefore require CE marking. It's unclear exactly how this works, in the sense that this seems to be one of the few areas of CE marking which is basically optional. It would be quite easy to argue that cable and wires are outside the scope of the LVD and therefore do not require a CE mark, but equally you could argue that they are within the scope and therefore should have the mark. The difference is basically made by what the manufacturer/seller claims the cable is to be used for. The advantage of carrying the mark (at least in theory) is, of course, unrestricted access to the whole EU marketplace so I guess savvy manufacturers tend to 'opt in' and mark their products. In practice, some cables, such as those which are specifically specified for use at mains voltages (e.g. house wiring, flexible cords for power connection of household appliances, etc) clearly are intended for use within the voltage limits of the LVD and must therefore be CE marked. There is an interesting (well, to CE anoraks like me, it's interesting anyway!) twist here, because fixed wiring in also within the scope of the Construction Products Directive, and CE marking is optional under this directive. However, the CPD is a whole new can of worms and it's far from clear what anyone is actually doing to comply with it, if anyone is actually seriously bothering at all. (If there's anyone else on this list with an interest in the CPD, I would be interested to hear from them, but I digress.) Again, the Commission guidance document on the LVD gives further guidance on this topic. Basically it says that if it's possible to do a safety assessment on the product, then such an assessment should take place and the CE mark should be applied, but if the component is so basic that its safety is totally reliant on how it is used then no such assessment is possible on the component itself and the CE mark should not be applied. I would tend to simplify this further and say that as a rule of thumb if there is a harmonised standard for the component under the LVD then it should be CE marked, and if there isn't it should not. To take the specific example of the surge protector, you need to be specific about that of which you speak. If you mean a component such as an MOV or a gas discharge tube, this is clearly a component and therefore outside the scope of the both LVD and the EMC Directive. If you mean an assembly in a box with connections (such as a telephone line lightning suppressor assembly) this can be assessed for safety and does require a CE mark under the LVD. An assembly such as this is not a component within the meaning of the EMC directive either, and will therefore need to comply with that directive too. Hope this sheds a little light for you. Regards Nick. At 09:36 -0800 12/12/2000, Courtland Thomas wrote: Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
Re: CE Marking Passive devices
Thanks to all who helpfully directed me to the web site with the details. Ralph Cameron - Original Message - From: Brian Jones e...@brianjones.co.uk To: Ralph Cameron ral...@igs.net; Courtland Thomas ctho...@patton.com; emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 2:39 PM Subject: Re: CE Marking Passive devices Ralph Toy Safety Directive, 88/378/EEC. For more information, have a look at www.europa.eu.int/scadplus/leg/en/lvb/121005.htm Best wishes Brian Jones EMC Consultant and Competent Body Signatory - Original Message - From: Ralph Cameron ral...@igs.net To: Courtland Thomas ctho...@patton.com; emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 5:16 PM Subject: Re: CE Marking Passive devices Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: CE Marking Passive devices
Yes, there is a reason. There is a Toy Directive which (I'm on unfamiliar ground here) deals mostly with child safety. As such, some really passive hunks of plastic (i.e. Barbie Dolls (and Ken Dolls, for gender equality) come with CE marks on them. When it comes to children, any piece of material, no matter how passive is suspected as a hazard. My understanding is that the Toy Directive requires testing to prove that toys don't present physical (i.e choking, strangulation) or chemical (i.e. toxicity) hazards to our most precious citizens. My guess is that the toys that you are thinking of are completely exempt from the EMC or Low Voltage Directives that most of us deal with. Their CE marking is probably based on the Toy Directive or some other non-electrical safety requirement. It's a whole different question than the one posed by Courtland regarding passive electrical components, which, I assume; aren't toys. Actually, along a different line of reasoning, (that doesn't apply to toys) I wonder if some manufacturers are CE marking items which are exempt from all of the New Approach directives? I wonder if they are affixing the CE mark as if to say, we're exempt from everything, so we must be CE approved? It could just be a way of ensuring that their goods don't get bottled up in customs. Happy Holidays! Chris -Original Message- From: Ralph Cameron [SMTP:ral...@igs.net] Sent: Tuesday, December 12, 2000 12:17 PM To: Courtland Thomas; emcpost Subject: Re: CE Marking Passive devices Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
Re: CE Marking Passive devices
There are a number of CE marking directives including 88/378/EEC Toy Safety. Before toys may be shipped into Europe they must be tested for safety and marked with the CE mark if they comply. The relevant standard is EN 71, Safety of Toys; Specification for Mechanical and Physical Properties. EN 50088 is a separate standard that covers the electrical safety of toys. A good list of the directives is available at: http://www.ace-help.co.uk/directs.html Ted Eckert Regulatory Compliance Engineer American Power Conversion Corporation ted.eck...@apcc.com The items contained in this e-mail reflect the personal opinions of the writer and are only provided for the assistance of the reader. The writer is not speaking in an official capacity for APC nor representing APC's official position on any matter. Ralph Cameron To: Courtland Thomas ctho...@patton.com, emcpost ralphc@igs.nemc-p...@majordomo.ieee.org et cc: Sent by: Subject: Re: CE Marking Passive devices owner-emc-pst c...@ieee.org 12/12/00 11:16 AM Please respond to Ralph Cameron Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single
Re: CE Marking Passive devices
Ralph Toy Safety Directive, 88/378/EEC. For more information, have a look at www.europa.eu.int/scadplus/leg/en/lvb/121005.htm Best wishes Brian Jones EMC Consultant and Competent Body Signatory - Original Message - From: Ralph Cameron ral...@igs.net To: Courtland Thomas ctho...@patton.com; emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 5:16 PM Subject: Re: CE Marking Passive devices Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: CE Marking Passive devices
Toys must meet the Toy Directive, which is completely separate from the EMC or LVD. Patty Elliot Ericsson Wireless Communications patricia.ell...@ericsson.com -Original Message- From: Ralph Cameron [mailto:ral...@igs.net] Sent: Tuesday, December 12, 2000 9:17 AM To: Courtland Thomas; emcpost Subject: Re: CE Marking Passive devices Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
CE Marking Passive devices
Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
Re: CE Marking Passive devices
Many passive plastic and paper toys coming from China carry the CE label. Is there a reason for it ? Ralph Cameron EMC Consultiant and Suppression of Consumer Electronics (After sale) - Original Message - From: Courtland Thomas ctho...@patton.com To: emcpost emc-p...@majordomo.ieee.org Sent: Tuesday, December 12, 2000 12:36 PM Subject: CE Marking Passive devices Hello group, I would like to know if there are any requirements for CE Marking a cable or any passive device, such as a basic surge protector. Thanks, Courtland Thomas Patton Electronics --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
